Endo-Model Knee System - Instruments

FDA UDI

Class I (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: Endo-Model Knee System - Instruments FDA UDI
Generic Name: Body femoral/tibial extension stem, uncoated FDA UDI
Device Name: Body femoral/tibial extension stem, uncoated - Endo Model Rotational and Hinge Knee System FDA UDI
Model / Reference: 151-307/03 FDA UDI
Description: Body femoral/tibial extension stem, uncoated - Endo Model Rotational and Hinge Knee System FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575289028 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Body femoral/tibial extension stem, uncoated FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Body femoral/tibial extension stem, uncoated

Endo-Model Knee System - Instruments by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body femoral/tibial extension stem, uncoated.

ELEOS Limb Salvage System — ONKOS SURGICAL, INC. · Class II
ELEOS™ — ONKOS SURGICAL, INC. · Class II
ELEOS™ — ONKOS SURGICAL, INC. · Class II
ELEOS™ — ONKOS SURGICAL, INC. · Class II
ELEOS™ — ONKOS SURGICAL, INC. · Class II
iTotal® Identity Cruciate Retaining Knee Replacement System — Conformis, Inc. · Class II
ELEOS™ — ONKOS SURGICAL, INC. · Class II
Pantheon System — ADLER ORTHO SPA · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: WALDEMAR LINK GmbH & Co. KG

Sources (1)

FDA UDI 509e61d3-bc9a-4b60-b5b3-28c2dd7c7efe 33 fields · synced May 30, 2026